Kornimate/medical-research-clean huggingface dataset:
a phase 3 study of bms-477118 in combination with metformin in subjects with type 2 diabetes who are not controlled with diet and exercise

Conditions: Diabetes

Summary: the purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

all subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. subjects who complete the short-term period will be eligible to enter the long term extension period. also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication

Eligibility criteria:
inclusion criteria: * type 2 diabetes * inadequate blood sugar control * no current treatment with other medications to lower blood sugar exclusion criteria: * major heart, liver or kidney problems * pregnant or breast feeding
korean idiopathic pulmonary fibrosis registry

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a multicenter prospective registry of ipf patients in south korea. the seoul national university bundang hospital is the coordination center for the korean ipf registry built by a collaboration of the korean interstitial lung diseases (ild) study group.

korean ild study group includes investigators of 30 hospitals. demographic, pulmonary function, laboratory data, chest ct findings and hospital course of ipf patients are collected.

Eligibility criteria:
inclusion criteria: * ipf patients diagnosed by multidisciplinary discussion exclusion criteria: * other interstitial lung diseases except for ipf * connective tissue disease-related ild * exposure-related ild
percussion device (pd) for detection of pneumothorax

Conditions: Pneumothorax

Summary: this study aims to examine the safety and efficacy of the percussion device in detecting a pneumothorax in patients that have undergone thoracic surgery.

a prospective, non-randomized clinical feasibility cohort study. the purpose of this feasibility study is to collect preliminary performance and safety information for the percussion device (pd). patients satisfying the inclusion criteria will be approached for study enrolment before their surgery in clinic. following surgery and after the patient's chest tube has been removed, evaluation of the chest using the pd and ultrasound will be performed by two independent assessors (a nurse practitioner or resident on the thoracic surgery team) prior to the post-removal cxr. details of study procedure are details in section 2.8. the pd's performance metric will be compared against cxr results, which is considered the gold standard in diagnosing a pneumothorax.

Eligibility criteria:
inclusion criteria: * all patients that have undergone an open or thoracoscopic thoracic procedure requiring a chest tube at london health sciences centre (lhsc), london, ontario. exclusion criteria: * patients less than 18 years old patients unable to consent patients with known persistent pneumothorax prior to chest tube removal patients who are pregnant patients with severe chest wall deformity.

Keywords: pneumothorax chest tube removal percussion
phase i study of ds-2741a in healthy volunteers and participants with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of ds-2741a after subcutaneous injection in healthy japanese male volunteers and japanese participants with moderate to severe atopic dermatitis.

this study consists of three parts. part 1 and part 3 are a single ascending and multiple dose study to assess the safety, pharmacokinetics and pharmacodynamics of ds-2741a after subcutaneous injection in healthy japanese male participants. part 2 is a single-dose study to assess the pharmacokinetics, safety, pharmacodynamics and efficacy of ds-2741a after subcutaneous injection in japanese participants with moderate to severe atopic dermatitis.

Eligibility criteria:
inclusion criteria: * for part 1 and part 3: * japanese healthy male subjects. * age ≥20 and ≤45 years upon providing informed consent. * body mass index (bmi) ≥18.5 and \<25.0 kg/m\^2 at screening. * for part 2: * japanese male or female, age ≥20 upon providing informed consent. * diagnosed with chronic atopic dermatitis (ad) at least 3 years before screening and by the criteria of hannifin and rajka at screening. exclusion criteria: * for part 1 and part 3: * having a history of atopic dermatitis * having a history of hypersensitivity to drugs or other substances or being idiosyncratic * having alcohol or drug dependence, etc. * for part 2: * having an active dermatological disease other than ad, which, in the investigator's opinion, would affect study assessments. * having a history of serious disease in the study potentially endangering the participant, as judged by the investigator or sub-investigator. * having a chronic or acute infection requiring treatment within 28 days before screening. * having superficial skin infections within 7 days before screening. * having a history of recurrent oral herpes and recurrent genital herpes. * having a history of parasitic infection or invasive, opportunistic infection such as histoplasmosis despite infection resolution, etc.

Keywords: atopic dermatitis ds-2741a
scalp infiltration with dexamethasone plus ropivacaine for post-craniotomy pain

Conditions: Pain, Postoperative

Summary: according to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. postoperative pain most often occurs within 48 hours after surgery. local infiltration of anesthesia is the most simple and effective analgesia. however, the analgesic effect only lasts for a short-time after surgery, and it cannot adequately meet the needs of postoperative analgesia after craniotomy. several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone. lipid microsphere is a relatively new drug delivery system. it is an artificial lipid emulsion. studies have shown that dexamethasone lipid microsphere, the dexamethasone palmitate emulsion (d-pal emulsion), has stronger anti-inflammatory effect than dexamethasone. therefore, the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective craniotomy under general anesthesia; * age 18-64 years; * american society of anesthesiologists (asa) physical status of i or ii; * anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively * patients required to fix their head in a head clamp during the operation. exclusion criteria: * previous history of craniotomy; * plan to delay extubation or no plan to extubate; * patients who cannot use the patient-controlled analgesia (pca) device; * patients who cannot comprehend the instructions of a numeric rating scale (nrs) before craniotomy; * body mass index (bmi) \ 35; * allergy to dexamethasone, lipid microsphere, opioids or ropivacaine; * history of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery; * history of uncontrolled epilepsy, psychiatric disorders or chronic headache; * pregnant or at breastfeeding; * symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction; * glasgow coma scale \<15 before the surgery; * intracranial hypertension; * peri-incisional infection; * patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.
coenzyme q10 as treatment for long term covid-19

Conditions: Covid19; Long Term Covid19

Summary: this study is a randomized, placebo-controlled, double-blinded, cross-over designed clinical trial investigating the effect of high-dose coenzyme q10 treatment in subjects with persisting symptoms more than 12 weeks af sars-cov-2 infection, long term covid-19 (ltc).

the aim is to investigate the effect of high-dose coenzyme q10 on number and severity of self-reported symptoms in patients with long term covid-19. the study will be conducted at the department of infectious diseases, aarhus university hospital in the ltc outpatient clinic. 120 study participants will be randomized 1:1 to receive placebo or coq10 in a dose of 500mg/day for 6 weeks. after a wash-out period of 4 weeks, participants are allocated to the opposite treatment for 6 weeks. the eq-5d-5l and an ltc-specific questionnaire are completed at baseline and after 6,10,16, and 20 weeks. at each of 5 visits blood samples will be collected from the participants for immunological investigations and assessment of cellular metabolism.

Eligibility criteria:
inclusion criteria: * age above 18 years. * able to give informed consent. * history of documented sars-cov-2 infection either by rt-pcr or antibody test. * symptoms related to long term covid-19, defined as being investigated, diagnosed and followed by specialized infectious diseases physicians in the long term covid-19 outpatient clinic, central region of denmark, aarhus university hospital. * symptoms not attributable to other co-morbidity/condition. exclusion criteria: * symptoms of acute covid-19, as defined by the danish health authorities. * women who are pregnant or breastfeeding, or with a positive pregnancy test as determined by a positive urine beta-human chorionic gonadotropin test during screening * hypersensitivity to the active ingredient or to any excipient of the medicinal product * known allergy to soy or peanuts. * individuals with reduced kidney or liver-function. * patients in anticoagulant therapy with vitamin k antagonists. * any condition that, in the investigator's opinion, will prevent adequate compliance with study therapy.

Keywords: coenzyme q10
agion catheter for preventing catheter-related bloodstream infections

Conditions: Catheter-Related Infections

Summary: the investigators assessed if use of agion-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (crbsi) in preterm infants.

recently, a silver zeolite-impregnated catheter has been commercialized. this material, namely the patented silver compound agion™, releases antimicrobially active silver ions which may help prevent catheter-related bloodstream infections crbsis which are frequent in preterm infant. the investigators hypothesized that the use of agion-impregnated umbilical catheters could decrease the occurrence of crbsis in preterm infants. to assess this hypothesis the investigators carried out a randomized controlled study in which preterm infants needing an umbilical vein catheter would received either an agion catheter or a traditional non-impregnated polyurethane catheter. infants with gestational age \< 30 weeks were randomized to receive an agion- impregnated or non-impregnated polyurethane umbilical venous catheter (uvc) by opening sealed opaque envelopes. the primary end point was the incidence of crbsis during the time the uvc was in place. the investigators studied 86 infants, 41 of whom received the agion catheter and 45 the non-impregnated catheter. during umbilical venous catheterization 2% of infants in the agion group developed crbsi in comparison with 22% of infants in the control group (p=0.005). the incidence density of crbsis during the study period was lower in infants who received agion catheters compared to the control group (2.1/1000 catheter days versus 25.8/1000 catheter days; p\<0.001). the occurrence of uvc colonization was similar in both groups. the kaplan-meier estimates of the cumulative likelihood of being free of a crbsi at each day of uvc placement demonstrate the statistically significant (p=0.004) protective effect of agion impregnated catheters. moreover, infants in the agion group had shorter hospital stay (p=0.04), and a lower case fatality rate due to bsi (p=0.01) than infants in the control group. agion catheters were well tolerated and none of patients showed signs attributable to silver toxicity. multivariate analysis demonstrated that non-impregnated catheter use (or 12.5, 95% c.l. 2.06-75.9) and catheter placement for more than 7 days (or 5.1, 95% c.l. 1.13-23.6) increased the risk of developing a crbsi in our population. conclusions. the agion-impregnated uvcs were effective in decreasing the development of crbsis in preterm infants compared to non-impregnated polyurethane uvcs.

Eligibility criteria:
inclusion criteria: * gestational age \< 30 weeks * need of an umbilical venous catheter in the first week of life * parental informed consent. exclusion criteria: * major congenital malformations * hydrops fetalis * inherited congenital metabolic diseases * death during the first week of life

Keywords: catheter related bloodstream infection umbilical venous catheter silver preterm infants
evaluation of efficacy and safety of ave5530 co-administered with atorvastatin in primary hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the present study is assessing the efficacy and safety of ave5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, ave5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. the main objective is to evaluate the effects of the association ave5530+atorvastatin on ldl-c level reduction after 12 weeks of treatment. the effects of ave5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

the study will include a 2 week pre-randomization placebo lead-in phase. there will be a 12- week double-blind treatment period for both components ave5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for ave5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular ldl-cholesterol monitoring. the treatment period can be variably extended up to approximately 18 months with double-blind for ave5530 component and open-label for atorvastatin.

Eligibility criteria:
inclusion criteria: * adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy exclusion criteria: * ldl-c levels \> 250 mg/dl (6.48 mmol/l) * triglycerides levels \> 350mg/dl (3.95 mmol/l) * conditions / situations such as: * presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels * active liver disease * high estimated risk of coronary heart disease * recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or unstable or severe peripheral artery disease * positive test for hepatitis b surface antigen and/or hepatitis c antibody or known to be human immunodeficient virus (hiv) positive * pregnant or breast-feeding women, * women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the investigational product * hypersensitivity to any component of atorvastatin * concurrent administration of cytochrome p450 3a4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: primary hypercholesterolemia
cannabinoid receptor function & alcoholism

Conditions: Alcoholism

Summary: this study attempts to characterize the effects of tetrahydrocannabinol (thc). tetrahydrocannabinol is the active ingredient of marijuana, cannabis, "ganja", or "pot". this study will involve healthy volunteers who 1) have no history of alcoholism in their family or 2) have a family history of alcoholism. this study looks at individuals with or without a family history of alcoholism to determine if there is a difference between the two groups in the response to thc.


Eligibility criteria:
inclusion criteria: * exposure to cannabis at least once exclusion criteria: * pregnancy
stress during elective or emergency cesarean operations

Conditions: Anxiety

Summary: we investigated a correlation between maternal anxiety and age, body mass index (bmi), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective c/s under general anesthesia.


Eligibility criteria:
inclusion criteria: * pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective c/s. exclusion criteria: * patients with cardiopulmonary, * renal, * hepatic or * psychiatric disease, * obstetric-fetal anomaly and * weighing ≥ 100 kg were excluded.

Keywords: cesarean operation spielberger state trait anxiety inventory pain
psychiatric disorders with prolonged infertility

Conditions: Psychiatric Disorder; Invitro Fertilization /Intracytoplasmic Spem Injection Failure

Summary: psychiatric disorders in women with prolonged infertility with or without ivf/icsi failure will be included then a questionnaire will be applied plus psychiatric examinatins

all patients will be recruited from both psychiatry and obstetrics and gynecology departments. referred cases from gynecologists and assisted reproductive technologies centers were also included. inclusion criteria: infertile couples infertility \>= 5 years invitro fertilization /intracytoplasmic spem injection failure for group 1 and not included for group 2

Eligibility criteria:
inclusion criteria: * infertile women * prolonged infertility ≥ 5 years * failed invitro fertilization /intracytoplasmic spem injection for group 1 * not bearing any children * accepting to share in the study. exclusion criteria: * patients with diagnosed psychiatric or neurologic disorders * patients with diabetes mellitus or any anatomical defects in genital tract * patients who didn't complete their questionnaires.
l-arginine supplementation and exercise; l-arginine supplementation and renal function

Conditions: Heart Transplantation

Summary: * exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction * cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by l-arginine supplementation * to determine the potential beneficial effect of l-arginine supplementation on exercise capacity and renal function of heart transplant recipients


Eligibility criteria:
inclusion criteria: * male (\> 18 years old) stable heart transplant recipient for at least 6 weeks * stable treatment for at least 3 months * sedentary people exclusion criteria: * unstable cardiac pathology * obesity (imc \> 40) * participation in another study in the last month * chronic renal failure (creatinine clearance \< 20 ml/min) * renal transplantation * diabetes * impossibility to practice exercise test * nitrate therapy

Keywords: l-arginine exercise capacity renal function nitric oxide exercise capacity using a maximal exercise test urinary elimination of a saline load using blood and urinary samples
health of babies born from ivf versus ivm at 5 years old

Conditions: Infertility; IVF; IVM; Development, Child

Summary: the investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (rct) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation ivm (capa ivm) compared with conventional ivf in order to give strong evidence about the safety of ivm in women with high antral follicle count.

the safety of the capa-ivm has also been proven by publications about the development of children born from this technique. data monitoring the physical, mental, and motor development of children born from the capa-ivm versus children born from the conventional ivf after 2 years under using the asq-3 tools and red flags showed that there were no significant differences in asq-3 scores at 6, 12 and 24 months between children born after ivm or ivf. the proportion of children with developmental red flags was low and did not differ between the two groups. slightly, but significantly, lower asq-3 problem-solving and personal-social scores in twins from the ivm versus ivf group at 6 months were still within the normal range and had caught up to the ivf group in the 12- and 24-month assessments. however, another question raised is whether there is a difference in the development of children born from capa-ivm compared to conventional ivf after a longer follow-up period. does the development between the two groups have a clinically significant difference? based on these questions, we decided to conduct an assessment of the physical, behavioural, mental, and motor development of children born from capa-ivm and conventional ivf up to 5 years after birth.

Eligibility criteria:
inclusion criteria: * all babies born following the in-vitro maturation and in-vitro fertilization from our fm study (nct03405701) participated in our previous follow-up study (nct04296357) * parents agree to participate in the study. exclusion criteria: * babies died under or at 60 months

Keywords: ivf ivm asq-3 childhood development
a study of safety, tolerability, and evidence of activity of fcfd4514s administered monthly or every other month to patients with geographic atrophy

Conditions: Geographic Atrophy

Summary: this is a phase ib/ii, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of fcfd4514s intravitreal injections administered monthly or every other month in patients with geographic atrophy.


Eligibility criteria:
inclusion criteria: * willingness and ability to provide signed informed consent; in addition, at u.s. sites, health insurance portability and accountability act (hipaa) authorization, in other countries, as applicable according to national laws * well-demarcated area of ga secondary to age-related macular degeneration (amd) in the absence of choroidal neovascularization (cnv) exclusion criteria: * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in the study eye * previous subfoveal focal laser photocoagulation in the study eye * laser photocoagulation in the study eye * prior treatment with visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye * ga in either eye due to causes other than amd * diabetic retinopathy in either eye * active or history of wet amd in either eye * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications * active malignancy or history of malignancy within the past 5 years * previous participation in any studies of investigational drugs within 3 months preceding day 0